CoChat
Sign Up
Cited by 14Substance Abuse Treatment and OutcomesHealth Policy Implementation ScienceAlcohol Consumption and Health Effects

Feasibility of a pragmatic randomized adaptive clinical trial to evaluate a brief negotiational interview for harmful and hazardous alcohol use in Moshi, Tanzania

Open access
Staton, Catherine A., Friedman, Kaitlyn, Phillips, Ashley J., Minnig, Mary Catherine, Sakita, Francis M., Ngowi, Kennedy M., Suffoletto, Brian, Hirshon, Jon Mark +3 more·2023·PLOS ONE
DOI 10.1371/journal.pone.0288458PMC PMC10399826
Open this paper in CoChat — free account

Abstract

Introduction: Low-resourced settings often lack personnel and infrastructure for alcohol use disorder treatment. We culturally adapted a Brief Negotiational Interview (BNI) for Emergency Department injury patients, the “Punguza Pombe Kwa Afya Yako (PPKAY)” (“Reduce Alcohol For Your Health”) in Tanzania. This study aimed to evaluate the feasibility of a pragmatic randomized adaptive controlled trial of the PPKAY intervention. Materials and methods: This feasibility trial piloted a single-blind, parallel, adaptive, and multi-stage, block-randomized controlled trial, which will subsequently be used to determine the most effective intervention, with or without text message booster, to reduce alcohol use among injury patients. We reported our feasibility pilot study using the Reach,Effectiveness,Adoption,Implementation,Maintenance(RE-AIM) framework, with recruitment and retention rates being our primary and secondary outcomes. We enrolled adult patients seeking care for an acute injury at the Kilimanjaro Christian Medical Center in Tanzania if they (1) exhibited an Alcohol Use Disorder Identification Test (AUDIT) ≥8, (2) disclosed alcohol use prior to injury, or (3) had a breathalyzer ≥0.0 on arrival.Intervention arms were usual care (UC), PPKAY, PPKAY with standard text booster, or a PPKAY with a personalized text booster. Results: Overall, 181 patients were screened and 75 enrolled with 80% 6-week, 82.7% 3-month and 84% 6-month follow-up rates showing appropriate Reach and retention.Adoption measures showed an overwhelmingly positive patient acceptance with 100% of patients perceiving a positive impact on their behavior. The Implementation and trial processes were performed with high rates of PPKAY fidelity (76%) and SMS delivery (74%). Intervention nurses believed Maintenance and sustainability of this 30-minute, low-cost intervention and adaptive clinical trial were feasible. Conclusions: Our intervention and trial design are feasible and acceptable, have evidence of good fidelity, and did not show problematic deviations in protocol. Results suggest support for undertaking a full trial to evaluate the effectiveness of the PPKAY, a nurse-driven BNI in a low-income country. Trial registration: Trial registration numberNCT02828267.https://classic.clinicaltrials.gov/ct2/show/NCT02828267.

Verified 2026-10-06 · 1 reference not checked yet

AI snapshot

Written from the paper’s full text.

TL;DR

This feasibility pilot of a pragmatic randomized adaptive trial found that a culturally adapted nurse-delivered Brief Negotiational Interview (PPKAY), with or without SMS boosters, was feasible and acceptable among injury patients with harmful/hazardous alcohol use in Moshi, Tanzania. Recruitment, retention, fidelity, and SMS delivery were adequate to support a full trial, though the study was not powered for effectiveness.

Key findings

Of 181 patients pre-screened, 75 (41%) were randomized over 12 weeks (average 6.25/week); follow-up retention was 80% at 6 weeks, 82.7% at 3 months, and 84% at 6 months.

  • Patient acceptability was high: 100% (n = 54) believed PPKAY had a positive impact on drinking behavior (98% large), 100% believed SMS boosters had a positive impact (91% large), and all participants reported nurses were the correct providers.
  • Implementation: 76% of PPKAY sessions had ≥19 of 22 critical actions on the BI Assessment Scale; 74% of attempted SMS texts were sent. The only protocol deviation was stopping SMS at 3 months instead of 6 months due to a staff communication error.
  • Effectiveness signals: DrInC and AUDIT scores decreased across all groups from baseline to 6 months; the paper reports intervention groups showed higher average decreases in DrInC and AUDIT at 6 months than usual care, with no observed negative effects, but the study was not powered for effect size.

Methods

Single-blind, parallel, adaptive, multi-stage block-randomized feasibility trial at Kilimanjaro Christian Medical Center ED in Moshi, Tanzania. Adult injury patients were eligible if they disclosed alcohol use prior to injury, scored ≥8 on AUDIT, or had breathalyzer >0.00 g/dL; arms were usual care, PPKAY, PPKAY with standard SMS booster, or PPKAY with personalized SMS booster.

  • The pilot planned ~70 participants and enrolled 75; follow-up was at 6 weeks, 3 months, and 6 months. Feasibility was reported using RE-AIM, with recruitment and retention as primary/secondary outcomes, plus descriptive outcome measures (DrInC, AUDIT, quantity/frequency, binge days), fidelity assessment via audio-recorded BI Assessment Scale, SMS delivery tracking, post-treatment acceptability surveys, and provider focus groups.

Limitations

Stated: as an initial feasibility trial, it was limited in size, scope, and generalizability; the sample was not powered to determine an effect size, so clinical significance must be interpreted cautiously; results likely not relevant to higher-income settings; participants needed mobile phone access and ability to reach the ED, possibly excluding lowest-income individuals; response bias is possible because interviews were conducted by the PI/nursing staff’s employer.

  • Evident from the text: SMS implementation was incomplete—only 258 of 492 expected texts (52%) were attempted, and the only protocol deviation was stopping SMS at 3 months rather than 6 months due to a staff communication error. There were also two envelope randomization errors, two assigned PPKAY patients discharged before receiving intervention, and two failed audio recordings for fidelity assessment.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1371/journal.pone.0288458

Cites

68 of 69 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 49 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    Retention rates were maintained at a minimum of 70% across each intervention arm at 6-week, 3-month, and 6-month follow-up.

    “Retention rates were maintained at a minimum of 70% across each intervention arm at 6-week, 3-month, and 6-month follow-up times for a final 6 month retention rate of 84% across all arms.”
    Quote in the paperSubstantial claim
  • Findingown data

    The 6-week follow-up rate was 80%.

    “Overall, 181 patients were screened and 75 enrolled with 80% 6-week, 82.7% 3-month and 84% 6-month follow-up rates showing appropriate Reach and retention.”
    Quote in the paperSubstantial claim
  • Findingown data

    The 6-month follow-up rate was 84%.

    “Overall, 181 patients were screened and 75 enrolled with 80% 6-week, 82.7% 3-month and 84% 6-month follow-up rates showing appropriate Reach and retention.”
    • Also stated in: § Reach · plain
      “Retention rates were maintained at a minimum of 70% across each intervention arm at 6-week, 3-month, and 6-month follow-up times for a final 6 month retention rate of 84% across all arms.”
    Quote in the paperSubstantial claim
  • Findingown data

    75 patients were enrolled/randomized.

    “Overall, 181 patients were screened and 75 enrolled with 80% 6-week, 82.7% 3-month and 84% 6-month follow-up rates showing appropriate Reach and retention.”
    • Also stated in: § Reach · plain
      “All patients who presented to the ED were pre-screened, 181 of whom consented for pre-randomization; of these, 41% (n = 75) met inclusion criteria and were randomized.”
    Quote in the paperSubstantial claim
  • Findingown data

    No potential negative effects of the interventions (increased drinking or loss of confidentiality) were observed.

    “We also assessed for any potential negative effects of the interventions, including whether increased drinking was observed in any participants or whether confidentiality was lost at any point in the study, and none were observed.”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim. 33
  • May combine two claims. 36

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    181 patients were screened for the trial.

    “Overall, 181 patients were screened and 75 enrolled with 80% 6-week, 82.7% 3-month and 84% 6-month follow-up rates showing appropriate Reach and retention.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Findingnone given

    Intervention nurses believed that maintenance and sustainability of the intervention and adaptive clinical trial were feasible.

    “Intervention nurses believed Maintenance and sustainability of this 30-minute, low-cost intervention and adaptive clinical trial were feasible.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The PPKAY intervention is low-cost.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The send rate was equal across each intervention arm.

    “This send rate was found to be equal across each intervention arm.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    100% of participants believed the SMS boosters had a positive impact on their behavior, with 91% reporting a large positive impact.

    “Similarly, 100% of participants believed that the SMS boosters had a positive impact on their behavior, with 91% reporting a large positive impact.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Findingown data

    Nurses felt confident about their ability to conduct this study in a full future trial.

    “Nurses also made it clear that they felt confident about their ability to conduct this study in a full future trial, and that they “will have time” to add the PPKAY to their workload.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    There was no reported loss of confidentiality and no increase in any alcohol-related measures.

    “There was no reported loss of confidentiality and no increase in any alcohol-related measures.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Findingreasoning

    Nurses believed a full future PRACT trial would be successful.

    “Nurses believed that the majority of patients enthusiastically participated in the PPKAY, indicating that they believed a full future PRACT trial would be successful since the participants “really like[d] … the counselling process” and even indicated a desire that the patient’s spouse receive counselling as well.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    At 6-month follow-up, among 54 respondents surveyed, 100% believed the PPKAY had a positive impact on their drinking behavior, and 98% reported a large positive impact.

    “At 6-month follow-up when asked specifically about the PPKAY or the SMS boosters, 100% (n = 54) of respondents surveyed believed that the PPKAY had a positive impact on their drinking behavior, with 98% reporting a large positive impact.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Nurses believed the training they received was sufficient, and that other counselors would be ready to conduct the intervention with the same training.

    “Our nurses also believed the training they received was sufficient, and that other counselors would be ready to conduct the intervention with the same training.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Findingown data

    Nurses stated they will have time to add the PPKAY to their workload.

    “Nurses also made it clear that they felt confident about their ability to conduct this study in a full future trial, and that they “will have time” to add the PPKAY to their workload.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Findingown data

    Nurses stated they were eager to administer PPKAY.

    “Nurses stated they were eager to administer PPKAY.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingreasoning

    3 participants left prior to their intervention and were not enrolled in the SMS text system, so 492 texts were expected.

    “We had 3 participants who left prior to their intervention and therefore were not enrolled in the SMS text system; therefore, we would expect 492 texts attempted.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Findingown data

    Nurses believed that the majority of patients enthusiastically participated in the PPKAY.

    “Nurses believed that the majority of patients enthusiastically participated in the PPKAY, indicating that they believed a full future PRACT trial would be successful since the participants “really like[d] … the counselling process” and even indicated a desire that the patient’s spouse receive counselling as well.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingnone given

    Nurses believed patients were interested in receiving this information and were eager to participate in the process.

    “They believed patients were interested in receiving this information and they were eager to participate in the process.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    The 6-month follow-up rate was 84%, compared to Sorsdahl's South African trial (54% completed 3-month follow-up) and Segatto's 85.2% 3-month follow-up in Brazil.

    “Similarly, our 6-month follow-up rate at 84% is promising when compared to Sorsdahl’s South African trial, where 54% completed 3-month follow-up [14], or Segatto’s 85.2% 3-month follow-up in Brazil [13].”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [14] K Sorsdahl, 2015, The efficacy of a blended motivational interviewing and problem solving therapy intervention to reduce substance use among patients presenting for emergency services in South Africa: A randomized controlled trial, Subst Abuse Treat Prev Policy source

      Not checked in the free run.

    • cites [13] ML Segatto, 2011, Brief motivational interview and educational brochure in emergency room settings for adolescents and young adults with alcohol-related problems: a randomized single-blind clinical trial, Rev Bras Psiquiatr source

      Not checked in the free run.

  • May combine two claims.

    Findingreasoning

    This study showed high intervention fidelity with the added ability of mobile health technology integration.

    “This study showed high intervention fidelity with the added ability of mobile health technology integration.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Each step of the pilot intervention occurred smoothly, without placing extra burdens on the research and nursing staff.

    “Otherwise, each step of our pilot intervention occurred smoothly, without placing extra burdens on the research and nursing staff conducting the study.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The SMS booster functioned well, required low maintenance, and was implemented easily.

    “Our innovative and previously untested SMS booster functioned well, required low maintenance, and was implemented easily.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    The PPKAY intervention and trial design have evidence of good fidelity.

    “Our intervention and trial design are feasible and acceptable, have evidence of good fidelity, and did not show problematic deviations in protocol.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The pilot study is registered with ClinicalTrials.gov registration number NCT02828267.

    “The pilot study is registered as “Evaluating a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania (BNI)” with ClinicalTrials.gov registration number is NCT02828267.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Interpretationreasoning

    The adaptive method allows answering multiple successive questions with streamlined enrollment and processes, thus enrolling fewer patients in the fully powered trial than if three successive clinical trials were used.

    “This adaptive method allows us to answer multiple successive questions with streamlined enrollment and processes; thus enrolling fewer patients in the fully powered trial than if we used three successive clinical trials.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    Implementation and trial processes were performed with high rates of PPKAY fidelity and SMS delivery.

    “The Implementation and trial processes were performed with high rates of PPKAY fidelity (76%) and SMS delivery (74%).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    A myriad of other high-income country studies have shown that a brief intervention administered specifically in an emergency department setting can reduce harmful alcohol use and its consequences up to 12 months post-injury and decrease the incidence of trauma recidivism.

    “A myriad of other high-income country (HIC) studies have shown that a BI administered specifically in an emergency department setting can reduce harmful alcohol use and its consequences up to 12 months post-injury [16–19] and decrease the incidence of trauma recidivism [20].”
    Quote in the paperSubstantial claim0 of 5 sources checked
    • cites [16] EFS Kaner, 2007, Effectiveness of brief alcohol interventions in primary care populations, Cochrane Database Syst Rev

      Not checked in the free run.

    • cites [17] C Elzerbi, 2015, A comparison of the efficacy of brief interventions to reduce hazardous and harmful alcohol consumption between European and non-European countries: a systematic review and meta-analysis of randomized controlled trials, Addiction source

      Not checked in the free run.

    • cites [18] S Kohler, 2015, Can motivational interviewing in emergency care reduce alcohol consumption in young people? A systematic review and meta-analysis, Alcohol Alcohol source

      Not checked in the free run.

    • cites [19] C Angus, 2014, Cost-effectiveness of a programme of screening and brief interventions for alcohol in primary care in Italy, BMC Fam Pract source

      Not checked in the free run.

    • cites [20] S Cordovilla-Guardia, 2017, Alcohol or drug use and trauma recidivism, Nurs Res source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    There is controversy around the best implementation strategy for a BI, such as the usefulness of boosters and the integration of mobile health technology for LMICs.

    “There is also controversy around the best implementation strategy for a BI, such as the usefulness of boosters that serve as scheduled reminders post-BNI [28–30] and the integration of mobile health technology for LMICs [31,32].”
    Quote in the paperNot a substantial claim0 of 5 sources checked
    • cites [28] G D’Onofrio, 2012, A brief intervention reduces hazardous and harmful drinking in emergency department patients, Ann Emerg Med source

      Not checked in the free run.

    • cites [29] J Gaume, 2008, Brief alcohol interventions: do counsellors’ and patients’ communication characteristics predict change?, Alcohol Alcohol source

      Not checked in the free run.

    • cites [30] R Longabaugh, 2001, Evaluating the effects of a brief motivational intervention for injured drinkers in the emergency department, J Stud Alcohol source

      Not checked in the free run.

    • cites [31] B Suffoletto, 2014, A text message alcohol intervention for young adult emergency department patients: a randomized clinical trial, Ann Emerg Med source

      Not checked in the free run.

    • cites [32] B Kool, 2014, Perceptions of adult trauma patients on the acceptability of text messaging as an aid to reduce harmful drinking behaviours, BMC Res Notes source

      Not checked in the free run.

  • May combine two claims.

    Study design and conductreasoning

    The study was not designed to determine the effectiveness of the intervention and the sample size was not powered to determine an effect size.

    “Our study was not designed to determine the effectiveness of the intervention and therefore the sample size was not powered to determine an effect size.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationnone given

    The PPKAY intervention and trial design did not show problematic deviations in protocol.

    “Our intervention and trial design are feasible and acceptable, have evidence of good fidelity, and did not show problematic deviations in protocol.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The KCMC ED reports a higher proportion of injury patients testing positive for alcohol compared to neighboring Mozambique (17%).

    “The KCMC ED reports a higher proportion of injury patients testing positive for alcohol compared to neighboring Mozambique (17%) [41], with alcohol use being associated with a 6-times increased risk of road traffic injury [42].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [41] CJ Cherpitel, 2018, Single episode of alcohol use resulting in injury: a cross-sectional study in 21 countries, Bull World Health Organ source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    A recent Cochrane review demonstrated moderate evidence that brief interventions can reduce alcohol consumption in primary care or emergency care settings for harmful and hazardous drinkers with no adverse effects, while longer interventions had little additional effect.

    “A recent Cochrane review demonstrated moderate evidence that brief interventions (BI) can reduce alcohol consumption in primary care or emergency care settings for harmful and hazardous drinkers with no adverse effects, while longer interventions had little additional effect [15].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [15] EF Kaner, 2018, Effectiveness of brief alcohol interventions in primary care populations, Cochrane Database Syst Rev

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    A few other mobile health-based interventions have been successful focusing on vaccination, medication adherence, and counseling for different health services.

    “In the KCMC community, mobile health technology is widely available, and a few other mobile health–based interventions have been successful focusing on vaccination [43], medication adherence [44,45], and counseling for different health services [46,47].”
    Quote in the paperNot a substantial claim0 of 5 sources checked
    • cites [43] J Ostermann, 2019, Do mobile phone-based reminders and conditional financial transfers improve the timeliness of childhood vaccinations in Tanzania? Study protocol for a quasi-randomized controlled trial, Trials source

      Not checked in the free run.

    • cites [44] IM de Sumari-de Boer, 2016, Feasibility of Real Time Medication Monitoring Among HIV Infected and TB Patients in a Resource-Limited Setting, AIDS Behav source

      Not checked in the free run.

    • cites [45] M Sumari-de Boer, 2019, Implementation and effectiveness of evriMED with short messages service (SMS) reminders and tailored feedback compared to standard care on adherence to treatment among tuberculosis patients in Kilimanjaro, Tanzania: proposal for a cluster randomized controlled trial, Trials source

      Not checked in the free run.

    • cites [46] K Hackett, 2019, “It makes you someone who changes with the times”: health worker and client perspectives on a smartphone-based counselling application deployed in rural Tanzania, Health Policy Plan source

      Not checked in the free run.

    • cites [47] FM Pima, 2019, Feasibility of Using Short Message Service and In-Depth Interviews to Collect Data on Contraceptive Use Among Young, Unmarried, Sexually Active Men in Moshi, Tanzania, and Addis Ababa, Ethiopia: Mixed Methods Study With a Longitudinal Follow-Up, JMIR Formativ Res source

      Not checked in the free run.

    • Rests on an assumption: Mobile health technology is widely available in the KCMC community.

  • May combine two claims.

    Interpretationown data

    The PPKAY intervention and the adaptive trial design are feasible and acceptable.

    “Our intervention and trial design are feasible and acceptable, have evidence of good fidelity, and did not show problematic deviations in protocol.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The PPKAY intervention is low-cost.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Alcohol use is associated with a 6-times increased risk of road traffic injury.

    “The KCMC ED reports a higher proportion of injury patients testing positive for alcohol compared to neighboring Mozambique (17%) [41], with alcohol use being associated with a 6-times increased risk of road traffic injury [42].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [42] CA Staton, 2018, The impact of alcohol among injury patients in Moshi, Tanzania: a nested case-crossover study, BMC Public Health source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Interpretationreasoning

    Results support undertaking a full trial to evaluate the effectiveness of the PPKAY, a nurse-driven BNI in a low-income country.

    “Results suggest support for undertaking a full trial to evaluate the effectiveness of the PPKAY, a nurse-driven BNI in a low-income country.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The study was approved by Duke University Medical Center IRB, Kilimanjaro Christian Medical Center Ethics Committee, and the Tanzanian National Institute of Medical Research.

    “This study was approved by the Duke University Medical Center Institutional Review Board (Pro00062061), Kilimanjaro Christian Medical Center Ethics Committee and the Tanzanian National Institute of Medical Research.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductcitation

    The BI Assessment Scale has good psychometric properties including inter- and intra-rater reliability with Kappa and ICC values above 0.80 and a strong ability to differentiate standard PPKAY sessions with poorly performed PPKAY sessions.

    “In prior work, our team adapted and validated the BI Assessment Scale [60] to the Tanzanian setting. It has good psychometric properties including inter- and intra-rater reliability with Kappa and ICC values above 0.80 and a strong ability to differentiate standard PPKAY sessions with poorly performed PPKAY sessions.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [60] MV Pantalon, 2012, Development of a scale to measure practitioner adherence to a brief intervention in the emergency department, J Subst Abuse Treat source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Changes to the protocol were published on ClinicalTrials.gov and approved by all relevant ethics bodies.

    “Changes to the protocol occurring during contextual and cultural input during intervention creation have been published on ClinicalTrials.gov and approved by all relevant ethics bodies.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    BNIs serve as a useful tool for moderating risky behaviors and can be administered by non-addiction specialized personnel.

    “While not intended for those with severe substance dependence, BNIs serve as a useful tool for moderating risky behaviors and can be administered by non-addiction specialized personnel [23–25].”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [23] KA Tansil, 2016, Alcohol electronic screening and brief intervention: A community guide systematic review, Am J Prev Med source

      Not checked in the free run.

    • cites [24] R Zoorob, 2014, Screening and brief intervention for risky alcohol use, Curr Probl Pediatr Adolesc Health Care source

      Not checked in the free run.

    • cites [25] S Rollnick, 2008, Motivational interviewing in health care: helping patients change behavior, COPD: Journal of Chronic Obstructive Pulmonary Disease source

      Not checked in the free run.

  • May combine two claims.

    Study design and conductreasoning

    Stopping guidelines were not created and power considerations were not taken into account in this feasibility study.

    “Similarly, as this is a feasibility study, stopping guidelines were not created and power considerations were not taken into account.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    At least 10 participants were included in each arm to test intervention/allocation protocols.

    “We included at least 10 participants in each arm to test intervention/allocation protocols.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    BI studies in Africa have reported a range of effectiveness and are focused around specific subsets of the population.

    “BI studies in Africa have reported a range of effectiveness and are focused around specific subsets of the population [26,27].”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [26] KL L’Engle, 2014, A randomized controlled trial of a brief intervention to reduce alcohol use among female sex workers in Mombasa, Kenya, J Acquir Immune Defic Syndr source

      Not checked in the free run.

    • cites [27] JR Mertens, 2014, Effectiveness of nurse-practitioner-delivered brief motivational intervention for young adult alcohol and drug use in primary care in South Africa: a randomized clinical trial, Alcohol Alcohol source

      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Interpretationown data

    The analyses found that improving communication for the multi-national team and organization and pre-planning for blinding and randomization processes are paramount.

    “Our analyses found that improving communication for our multi-national team and organization and pre-planning for our blinding and randomization processes are paramount; but it also showed these processes are feasible in our setting, as we had only minimal protocol deviations.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Sorsdahl and colleagues focused on a MI-Problem Solving combination treatment and thus was likely not powered to evaluate the MI only arm.

    “While Sorsdahl and colleagues focused on a MI-Problem Solving combination treatment and thus was likely not powered to evaluate the MI only arm [14].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [14] K Sorsdahl, 2015, The efficacy of a blended motivational interviewing and problem solving therapy intervention to reduce substance use among patients presenting for emergency services in South Africa: A randomized controlled trial, Subst Abuse Treat Prev Policy source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Segatto et al. compared a MI against an educational pamphlet control group.

    “Segatto et al. compared a MI against an educational pamphlet control group [13].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [13] ML Segatto, 2011, Brief motivational interview and educational brochure in emergency room settings for adolescents and young adults with alcohol-related problems: a randomized single-blind clinical trial, Rev Bras Psiquiatr source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Concerns surround limited nursing staff time to conduct the intervention, especially in a busy ED, and perception of preparedness to discuss harm reduction strategies with participants.

    “Concerns surround limited nursing staff time to conduct the intervention, especially in a busy ED, and perception of preparedness to discuss harm reduction strategies with participants [64].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [64] L Platt, 2016, How effective are brief interventions in reducing alcohol consumption: do the setting, practitioner group and content matter? Findings from a systematic review and metaregression analysis, BMJ Open source

      Not checked in the free run.

  • May combine two claims.

    Interpretationown data

    The RE-AIM framework synthesis demonstrated successful trial feasibility, including good recruitment and retention, high intervention fidelity, and high rates of patient and provider acceptability.

    “We used the RE-AIM framework as a way to synthesize our results, which demonstrated successful trial feasibility, including good recruitment and retention, high intervention fidelity, and high rates of patient and provider acceptability.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The study demographic is expected based on prior studies.

    “The study demographic is expected based on prior studies [40,42].”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [40] CA Staton, 2017, A prospective registry evaluating the epidemiology and clinical care of traumatic brain injury patients presenting to a regional referral hospital in Moshi, Tanzania: challenges and the way forward, Int J Inj Contr Saf Promot source

      Not checked in the free run.

    • cites [42] CA Staton, 2018, The impact of alcohol among injury patients in Moshi, Tanzania: a nested case-crossover study, BMC Public Health source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    PPKAY is a BNI created and piloted at KCMC, based upon US-based BNI standards and adapted to Swahili and the Tanzanian environment.

    ““Punguza Pombe Kwa Afya Yako” (PPKAY)/ “Reduce Alcohol for Your Health” is a BNI created and piloted at the Kilimanjaro Christian Medical Centre in Moshi, Tanzania. PPKAY was based upon US-based BNI standards [36] and adapted to Swahili and the Tanzanian environment [37,38].”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [36] D’Onofrio G, Pantalon MV, Degutis LC, DA Fiellin, O’Connor PG. Screening and brief intervention for unhealthy alcohol use in the ED. Section of Emergency Medicine and Departments of Psychiatry and Medicine; Yale University School of Medicine; 2004. Available: https://bigsbirteducation.webs.com/ACEP%20brief%20negotiated%20intervention%20manual.pdf.

      Not checked in the free run.

    • cites [37] A Zimmerman, 2021, Cultural adaptation of a brief intervention to reduce alcohol use among injury patients in tanzania, medRxiv

      Not checked in the free run.

    • cites [38] Staton CA. Trial Protocol: Evaluating a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania. In: ClinicalTrials.gov [Internet]. [cited 2 Dec 2021]. Available: https://clinicaltrials.gov/ct2/show/NCT02828267.

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The two patients who did not receive PPKAY were followed as normal per protocol of the planned intention-to-treat analysis.

    “These two patients were followed as normal as per protocol of the planned intention to treatment analysis.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Only two of these studies enrolled participants from an emergency department, both used MI principles but vastly different interventions and did not compare MI to usual care.

    “Only two of these studies enrolled participants from an emergency department, both of which used MI principles but vastly different interventions and did not compare MI to usual care.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    The analyses showed that blinding and randomization processes are feasible in our setting, as we had only minimal protocol deviations.

    “Our analyses found that improving communication for our multi-national team and organization and pre-planning for our blinding and randomization processes are paramount; but it also showed these processes are feasible in our setting, as we had only minimal protocol deviations.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In two instances, the audio tape recordings failed to record patient interview sessions to assess intervention fidelity.

    “In two instances, the audio tape recordings failed to record patient interview sessions to assess intervention fidelity.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationown data

    The difference between expected and attempted texts highlighted the need for more close weekly monitoring of the SMS system.

    “This difference highlighted the need for more close weekly monitoring of our SMS system.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Treatment of alcohol use disorders in LMICs, where it exists, has been focused on long-term residential treatment centers with limited overall efficacy and no evidence for moderate alcohol users with harmful or hazardous drinking.

    “Treatment of alcohol use disorders in LMICs, where it exists, has been focused on long-term residential treatment centers with limited overall efficacy and no evidence for moderate alcohol users with harmful or hazardous drinking [8–10].”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [8] V Benegal, 2009, Packages of care for alcohol use disorders in low- and middle-income countries, PLoS Med source

      Not checked in the free run.

    • cites [9] U Perngparn, 2008, Drug and alcohol services in middle-income countries, Curr Opin Psychiatry source

      Not checked in the free run.

    • cites [10] R Kohn, 2004, The treatment gap in mental health care, Bull World Health Organ

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Interpretationnone given

    SMS messages may have reminded assigned individuals of their ongoing participation in the trial, perhaps contributing to their willingness to continue participation.

    “Additionally, SMS messages may have reminded assigned individuals of their ongoing participation in the trial, perhaps contributing to their willingness to continue participation.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Interpretationnone given

    Activities described in the methods section may have contributed to high rates of follow-up.

    “Activities described in the methods section may have contributed to high rates of follow-up.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    This feasibility trial demonstrated successful recruitment, enrollment, and follow-up in a pilot PRACT of a nurse-led BNI aimed at reducing harmful alcohol use in a low-income country emergency department.

    “This feasibility trial demonstrated successful recruitment, enrollment, and follow-up in a pilot pragmatic randomized adaptive clinical trial (PRACT) of a nurse-led BNI aimed at reducing harmful alcohol use in a low-income country emergency department.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Studies examining the feasibility and efficacy of SMS message boosters in BIs for alcohol use have taken place in HICs, but evidence is lacking on their use in LMICs, such as Tanzania.

    “Previously, studies examining the feasibility and efficacy of SMS message boosters in BIs for alcohol use have taken place in HICs [33,67], but evidence is lacking on their use in LMICs, such as Tanzania.”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [33] EF Kaner, 2017, Personalised digital interventions for reducing hazardous and harmful alcohol consumption in community-dwelling populations, Cochrane Database Syst Rev

      Not checked in the free run.

    • cites [67] K Thomas, 2017, Short message service (SMS)-based intervention targeting alcohol consumption among university students: study protocol of a randomized controlled trial, Trials source

      Not checked in the free run.

    • Rests on an assumption: Evidence is lacking on the use of SMS message boosters in BIs for alcohol use in LMICs, such as Tanzania.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationreasoning

    The positive response to PPKAY may be due to familiarity.

    “Both nurses and patients responded positively to PPKAY, potentially due to familiarity.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In an attempt to address potential bias, nursing staff were asked directly about the specific barriers they faced during enrollment, randomization, and follow-up stages.

    “In an attempt to address this potential bias, nursing staff were asked directly about the specific barriers they faced during enrollment, randomization, and follow-up stages.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    Integration of SMS mobile health technology was shown to be feasible and acceptable in this population.

    “Integration of SMS mobile health technology was also shown to be feasible and acceptable in this population.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

    Interpretationreasoning

    The results are likely not relevant to higher-income country settings.

    “In terms of generalizability, it is important to consider the demographic and patient profile of this study, and that the results are likely not relevant to higher-income country settings.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    Response bias is possible given that interviews were conducted by the study PI, the research nursing staff's employer.

    “It is important to note, however, that response bias is possible given that interviews were conducted by the study PI, the research nursing staff’s employer.”
    Quote in the paperNot a substantial claim
61 of 61

  • The paper relies on this without support.

    Mobile health technology is widely available in the KCMC community.

    “In the KCMC community, mobile health technology is widely available, and a few other mobile health–based interventions have been successful focusing on vaccination [43], medication adherence [44,45], and counseling for different health services [46,47].”

  • The paper relies on this without support.

    There were no other treatment options for severe alcohol use disorder in this setting.

    “As there were no other treatment options, denying study participation to those with severe AUD was considered unethical.”

  • The paper relies on this without support.

    The PPKAY intervention is low-cost.

    “Intervention nurses believed Maintenance and sustainability of this 30-minute, low-cost intervention and adaptive clinical trial were feasible.”

  • The paper relies on this without support.

    This is the first study to examine the feasibility of conducting an adaptive clinical trial of a culturally adapted brief negotiational interview for injury patients in a low-income country (Tanzania).

    “To our knowledge, this is the first feasibility study of an adaptive clinical trial evaluating a culturally adapted brief negotiational interview for injury patients in a low income setting.”
    “While BNI has been studied and shown to successfully reduce alcohol-related harms in numerous HIC studies [64] and in LMIC [65], this is the first study to examine the feasibility of conducting such a trial in a low-income country—Tanzania.”

  • The paper relies on this without support.

    Injuries and alcohol use are primarily observed among men in this setting.

    “This is because injuries and alcohol use are primarily observed among men in this setting.”

  • The paper relies on this without support.

    Adaptive clinical trials are gaining popularity but have rarely been used in behavioral science or global health.

    “While adaptive clinical trials are gaining popularity, they have rarely been used in behavioral science or global health.”

  • The paper relies on this without support.

    Challenges to intervention feasibility identified in HIC settings have mainly included sustainability concepts.

    “Challenges to intervention feasibility identified in HIC settings have mainly included sustainability concepts.”

  • The paper relies on this without support.

    Evidence is lacking on the use of SMS message boosters in BIs for alcohol use in LMICs, such as Tanzania.

    “Previously, studies examining the feasibility and efficacy of SMS message boosters in BIs for alcohol use have taken place in HICs [33,67], but evidence is lacking on their use in LMICs, such as Tanzania.”

  • The paper relies on this without support.

    Young healthy men seen in an ED are traditionally a difficult population for follow-up.

    “While young healthy men seen in an ED are traditionally a difficult population for follow-up, our enrollment rates were relatively high (41%, 75 of 181 screened) compared to Sorsdahl’s ED-based brief intervention clinical trials (12%, 335 of 2736) in South Africa [14].”
9 of 9

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Single-session brief interventions resulted in reduced alcohol use at 6 weeks.

    “Concerning alcohol use, single session BI resulted in reduced use at month 1 [50,54]; 6 weeks [72], 3 months [50,61–64], and 6 months [50,52,60,72].”

    From A scoping review of substance use brief interventions in Africa (2024) · cites this paper as [72]

    The Results (Effectiveness, Table 4; page unavailable) report lower AUDIT scores at 6 weeks than at baseline in the PPKAY-only arm, but scores also fell in the usual-care arm. The Discussion (Intervention feasibility: Efficacy; page unavailable) calls the intervention findings a preliminary signal and says the trial was not powered to determine an effect size. The paper therefore does not establish that the single-session intervention caused the reduction. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

  • Single-session brief interventions resulted in reduced alcohol use at 6 months.

    “Concerning alcohol use, single session BI resulted in reduced use at month 1 [50,54]; 6 weeks [72], 3 months [50,61–64], and 6 months [50,52,60,72].”

    From A scoping review of substance use brief interventions in Africa (2024) · cites this paper as [72]

    The Results > Effectiveness section (page unavailable) reports lower AUDIT scores at six months than at baseline, including in the brief-intervention-only group. But scores also fell in usual care, and the Methods > Statistical analysis considerations section says the feasibility trial was not powered to determine effectiveness; it does not establish that a single-session intervention caused the reduction. (LLM, conf=0.87)

    Experimental — accuracy not yet measured

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Overall monthly income does not match its USD conversion

    Minor

    Using the exchange rate stated beneath Table 3, the reported overall mean of 185,500 TSH is approximately 81.68 USD, not the reported 83 USD.

    Reported 83 · recomputed 81.682078

  • RE-AIM objectives are attributed to the enrollment table

    Minor

    The text directs readers to Table 2 for the RE-AIM framework, but Table 2 contains planned enrollment; the RE-AIM objectives appear in Table 1.

  • Stage 3 allocation ratio cannot fit a 12-patient block

    Minor

    An exact 1:4 allocation requires a block size divisible by five. The stated fixed block size of 12 therefore cannot maintain that ratio within each Stage 3 block.

  • Breathalyzer eligibility uses conflicting thresholds

    Minor

    The abstract permits a breathalyzer reading of zero to satisfy this eligibility criterion, whereas the methods require a reading greater than zero.

4 of 4

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Related

Authors
Staton, C. A., Friedman, K., Phillips, A. J., Minnig, M. C., Sakita, F. M., Ngowi, K. M., Suffoletto, B., Hirshon, J. M., Swahn, M., Mmbaga, B. T., & Vissoci, J. R. N.
Affiliations
  • Duke University (US)
  • Kilimanjaro Christian Medical Centre (TZ)
  • Kilimanjaro Clinical Research Institute (TZ)
  • University of Pittsburgh (US)
  • University of Maryland, Baltimore (US)
  • Georgia State University (US)
Corresponding author
Staton, Catherine A.
ORCID
Venue
PLOS ONE
Publisher
Public Library of Science (PLoS)
Published
2023-08-03
Volume
18
Issue
8
Pages
e0288458
ISSN
1932-6203 (ISSN-L)
DOI
10.1371/journal.pone.0288458
PMC
PMC10399826
OpenAlex
W4385520653
Semantic Scholar
89cedd3e708eade577470fba2ac6c6d299c10955
Cited by
14
References
68
Citations by year
2026: 2 · 2025: 3 · 2024: 7 · 2023: 2
FWCI
2.80
Type
journal article
Language
en
Open access
Licence
Locations
  • PLoS ONE (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • RePEc: Research Papers in Economics (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
Fogarty International Center (K01-TW010000-01A1, 1R01AA027512-01A1)
Topics
  • Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
Keywords
hazardous drinking, alcoholism, emergency department patients, trauma patients, culturally tailored interventions, feasibility, RE-AIM framework, resource-limited settings, Tanzania
MeSH terms
Adaptive Clinical Trials as Topic, Adult, Alcoholism, Feasibility Studies, Humans, Pilot Projects, Tanzania, Randomized Controlled Trials as Topic, Single-Blind Method

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-06.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-06.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review